A PK/PD of Synacthen Formulations Administered by Different Routes

• Research type

  Research Study

• Full title

  A Single Dose Randomized Study in Healthy Volunteers to Compare the Pharmacokinetics, Pharmacodynamics and Tolerability of Synacthen Formulations given by Different Routes of Administration (IV, SC, IM).

• IRAS ID

  184138

• Contact name

  Brown Fran

• Sponsor organisation

  Mallinckrodt Pharmaceuticals, Inc

• Eudract number

  2015-002597-20

• Duration of Study in the UK

  0 years, 0 months, 24 days

• Research summary

  The active ingredient in Synacthen products is Tetracosactide (beta1-24-corticotrophin). Tetracosactide is available in two forms: (1) Synacthen Solution, which is available as a solution for administration by intravenous or intramuscular injection and (2) a longer acting form, Synacthen Depot, which is a suspension of tetracosactide adsorbed to zinc phosphate as hexaacetate and which is given by intramuscular injection.

  Synacthen IM/IV (tetracosactide) was first approved for use in 1965 and is currently registered in 35 countries and is generally used as a diagnostic agent to investigate adrenocortical insufficiency and as an alternative to Synacthen Depot where IV injection or infusion is preferred.

  Synacthen Depot (tetracosactide hexaacetate) was first approved in 1967 and is currently approved in 55 countries for therapeutic use in the following indications: neurological conditions (e.g. acute exacerbations of multiple sclerosis, West syndrome), rheumatic diseases (e.g. rheumatoid arthritis), skin diseases (e.g. pemphigus, severe chronic eczema, erythrodermal or pustular forms of psoriasis), nephrotic syndrome, diseases of the gastrointestinal tract (e.g. ulcerative colitis, regional enteritis), and in oncology (as an adjuvant therapy to improve the tolerability of chemotherapy)

  Given the limitations of published information this study is being performed to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ACTH (1-24) following single doses of Synacthen® Depot and Synacthen Solution ® via different routes of administration (IV, SC, IM). This will allow the properties of Synacthen Depot given SC to be characterized fully.

• REC name

  HSC REC B

• REC reference

  15/NI/0151

• Date of REC Opinion

  18 Aug 2015

• REC opinion

  Favourable Opinion